Pre-op Use of Incentive Spirometry in Obese Patients

NCT01004146 | Completed Results DMC

• 1 other identifier: HSC-MS-08-0622
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the use of preoperative incentive spirometry (IS) as an aid to improve postoperative lung function. The hypothesis is that application of a standardized protocol of preoperative respiratory care teaching and exercise will improve lung performance that will subsequently result in prevention of postoperative pulmonary complications and that increasing the duration of preoperative use better improves lung mechanics postoperatively. The investigators propose to compare a patient population that uses IS as currently prescribed in the routine course of care (only to be familiar with preoperatively, but use postoperatively) against a population that uses IS with a standardized regimen for at least 3 days prior to the operation in terms of preoperative IS volumes, intraoperative pulmonary mechanics, postoperative IS volumes, and incidence of postoperative pulmonary complications.

Conditions

Lung Function; Bariatric Surgery

Keywords

incentive spirometry; bariatric surgery; obesity

Outcome Measures

Primary Outcomes (1)

• Post Operative Incentive Spirometry Volume

  After the operation, the patients to be discharged on the same day were approached in the postanesthesia care unit (PACU) and requested to use the spirometer again. The volume (best out of 2 attempts) was recorded together with the same vital signs recorded preoperatively. Patients who were admitted to the hospital were requested to use the spirometer again on postoperative day 1. The largest IS volume (out of 2 attempts) was recorded. The data presented is the mean largest IS volume the day after surgery.

  1 week before surgery to the day after

Secondary Outcomes (4)

• Level of Compliance

  3 days to 2 weeks after clinic visit on the day of surgery

• Oxygen Saturation

  one week prior to surgery up to one day after

• Heart Rate

  one week prior to surgery to post operative day 1

• Respiratory Rate

  one week prior to surgery to post operative day 1

Study Arms (2)

Control group

PLACEBO COMPARATOR

Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.

Procedure: Incentive Spirometry

Experimental Group

EXPERIMENTAL

Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.

Procedure: Incentive Spirometry

Interventions

Incentive Spirometry PROCEDURE

helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse

Control group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• morbid obesity
• bariatric surgery
• must be able to use incentive spirometer

You may not qualify if:

• BMI=\<40 kg/m2
• current symptoms of obstructive sleep apnea or actively using continuous positive airway pressure

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Our analysis was limited to measuring lung volumes up until postoperative day 1.Extending this study a few days postoperatively likely would allow us to achieve a better understanding of the course of respiratory function recovery.

Results Point of Contact

• Title: Dr. Davide Cattano
• Organization: University of Texas at Houston Medical School / Dept. of Anesthesiology

davide.cattano@uth.tmc.edu

713-500-6235

Study Officials

• Davide Cattano, M.D.

  University of Texas Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proffessor

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: October 29, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: September 1, 2010
• Last Updated: February 3, 2014
• Results First Posted: February 3, 2014

Record last verified: 2013-12

Locations

US (1)